Inpharma 1301 - 18 Aug 2001 Finasteride/tamsulosin: no serious, unexpected adverse events No serious, unexpected adverse events associated with finasteride or tamsulosin were seen in a review of 2 large, observational cohort studies conducted in the UK, which utilised prescription event monitoring, report researchers from the UK. The 2 studies involved 14 772 finasteride recipients and 12 484 tamsulosin recipients, who were predominantly men (mean age 69 and 62.2 years, respectively), with 2 and 70 woman in each cohort, respectively. * Data were collected approximately 6 months after treatment initiation, between October 1992 and February 1994, for finasteride, and after approximately 12 months’ treatment, between June 1996 and January 1998, for tamsulosin. Both finasteride and tamsulosin were well tolerated, with 69.6 and 62% of patients from each cohort still receiving their respective agent after 6 months’ treatment. Reported adverse events were consistent with the known pharmacology of the 2 drugs, and occurred in 95 and 226 of the finasteride and tamsulosin recipients, respectively [see table]. No deaths deemed attributable to either agent were reported, nor were there any serious, unexpected adverse events. The researchers note that, although uncommon, cases of gynaecomastia with finasteride, and hypotension and/or dizziness with tamsulosin, ‘are worth an appropriate level of precautionary interest in patients in whom they might have adverse consequences’. Table. Ten most frequent adverse events associated with finasteride and tamsulosin in 2 large observational cohort studies Finasteride (n = 14 772) Tamsulosin (n = 12 484) Adverse Number of Adverse Number of event patients event patients Impotence 10 Dizziness 10 Headache 5 Nausea 10 Rash 5 Palpitations 10 Dizziness 4 Headache 9 Gynaecomastia 4 Lassitude 9 Breast 3 Hypotension 8 disorders Dyspepsia 3 Drowsiness 7 Intolerance 3 Dry mouth 5 Decreased 3 Rash 5 libido Nausea 3 Retrograde 4 ejaculation * The women received the drugs mainly for miscellaneous urinary conditions. Shakir S, et al. Finasteride and tamsulosin used in benign prostatic hypertrophy: a review of the prescription-event monitoring data. BJU International 87: 789-796, No. 9, Jun 2001 800869919 1 Inpharma 18 Aug 2001 No. 1301 1173-8324/10/1301-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Finasteride/tamsulosin: no serious, unexpected adverse events

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Inpharma 1301 - 18 Aug 2001

Finasteride/tamsulosin: no serious,unexpected adverse events

No serious, unexpected adverse events associatedwith finasteride or tamsulosin were seen in a review of 2large, observational cohort studies conducted in the UK,which utilised prescription event monitoring, reportresearchers from the UK.

The 2 studies involved 14 772 finasteride recipientsand 12 484 tamsulosin recipients, who werepredominantly men (mean age 69 and 62.2 years,respectively), with 2 and 70 woman in each cohort,respectively.* Data were collected approximately 6months after treatment initiation, between October1992 and February 1994, for finasteride, and afterapproximately 12 months’ treatment, between June1996 and January 1998, for tamsulosin.

Both finasteride and tamsulosin were well tolerated,with 69.6 and 62% of patients from each cohort stillreceiving their respective agent after 6 months’treatment. Reported adverse events were consistentwith the known pharmacology of the 2 drugs, andoccurred in 95 and 226 of the finasteride and tamsulosinrecipients, respectively [see table]. No deaths deemedattributable to either agent were reported, nor werethere any serious, unexpected adverse events.

The researchers note that, although uncommon,cases of gynaecomastia with finasteride, andhypotension and/or dizziness with tamsulosin, ‘areworth an appropriate level of precautionary interest inpatients in whom they might have adverseconsequences’.

Table. Ten most frequent adverse events associatedwith finasteride and tamsulosin in 2 largeobservational cohort studiesFinasteride (n = 14 772) Tamsulosin (n = 12 484)

Adverse Number of Adverse Number ofevent patients event patients

Impotence 10 Dizziness 10Headache 5 Nausea 10Rash 5 Palpitations 10Dizziness 4 Headache 9Gynaecomastia 4 Lassitude 9Breast 3 Hypotension 8disorders

Dyspepsia 3 Drowsiness 7Intolerance 3 Dry mouth 5Decreased 3 Rash 5libido

Nausea 3 Retrograde 4ejaculation

* The women received the drugs mainly for miscellaneous urinaryconditions.

Shakir S, et al. Finasteride and tamsulosin used in benign prostatic hypertrophy: areview of the prescription-event monitoring data. BJU International 87: 789-796,No. 9, Jun 2001 800869919